Antibiotics, Implantable Defibrillator User, Pacemaker Electrode Infection, Post Procedural Infection
Conditions
Keywords
Prophylactic antibiotics, Cardiac implantable electronic device infection
Brief summary
This study is a multi-center open-label randomized study, and we sought to investigate the redundancy of post-procedural prophylactic antibiotics in cardiac implantable electronic device implantation. There are 2 arms in this study. One arm will receive pre-procedural intravenous antibiotics only. The other arm will receive both pre-procedural intravenous antibiotics and post-procedural 3-day oral antibiotics.
Detailed description
There is general agreement on the benefits of preoperative prophylactic antibiotics which had been documented in previous studies. Concerns of bacterial resistance and unnecessary cost, our prospective observational case-control study had suggested the redundancy of post-procedural antibiotics. In this well-designed study, we sought to investigate the efficacy of post-procedural antibiotics and confirm the hypothesis.
Interventions
DRUGAntibiotics
Post-procedural one-day iv cefazolin then 3-day prophylactic cephalexin
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This study is a multi-center, prospective, randomized and open-labeled study.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible for permanent pacemaker or implantable cardioverter defibrillator implantation according to current guidelines
Exclusion criteria
* Hospitalization for more than 7 days * End stage renal disease with hemodialysis or peritonealysis * Patients receive cardiac resynchronization therapy, His-bundle pacemaker, leadless pacemaker, or sub-cutaneous implantable cardioverter defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac implantable electronic device related infection | 1 year | Any local and systemic signs/symptoms (pocket erosion, localized pocket erythema, swelling, heatness, pain, fever, bacteremia, lead/valvular vegetation) will be monitored during follow-up. The definition and classification of CIED related infection are based on the current guideline and expert consensus statement. |
Countries
Taiwan
Contacts
Primary ContactHui-Chen Chiang, Bachelor
Backup ContactTing-Chun Huang, MD
Outcome results
None listed